Strengthening Bolivian Pharmacovigilance system: new therapeutic strategies to improve health of Chagas Disease and Tuberculosis patients

Abstract

2 Introduction: Chagas disease (CD) and Tuberculosis (TB) are important health problems in 3 Bolivia. Current treatments for both infections require a long period of time, and unwanted 4 drug-related adverse events (ADRs) are frequent. 5 Purpose: This study aims to strengthen the Bolivian Pharmacovigilance system, focusing on CD 6 and TB. 7 Methods: A situational diagnosis of Pharmacovigilance in the Department of Cochabamba was 8 performed. The use of a new Local Case Report Form (CRF) was implemented, together with 9 the CRF established by the Unidad de Medicamentos y Tecnología en Salud (UNIMED), in 10 several health care centers. Training and follow-up on drug safety monitoring and ADR 11 reporting was provided to all health professionals involved in CD and TB treatment. A 12 comparative analysis of the reported ADRs using the CRF provided by UNIMED, the new CRF 13 proposal, and medical records, was performed. 14 Results: Out of the total patients starting treatment for CD, 35,35% suffered ADR according to 15 the information collected in the medical records, and 25% of them were classified as 16 moderate/severe (MS) types. Only 51,43% of MS ADRs were reported to UNIMED. Regarding 17 TB treatment, 9,89% of the total patients suffered ADR, 44% of them were classified as MS, 18 and 75% of MS ADRs were reported to UNIMED. 19 Conclusions: The reinforcement of the Bolivian Pharmacovigilance system is an ambitious 20 project that should take a long-term perspective and the engagement of national health 21 workers and other stake holders at all levels. Continuity and perseverance are essential to 2 22 achieve a solid ADR reporting system, improving patient safety, drug efficacy and adherence to 23 treatment. 24

Strategies to enhance access to diagnosis and treatment for Chagas disease patients in Latin America

“…Results of an unpublished study conducted by Cortes-Serra et al in Bolivia during 2016 indicate that 35.4% of the total patients treated for Chagas disease in 14 healthcare centers of the department of Cochabamba suffered ADRs related to it. From all ADRs classified as moderate or severe (25% of the total ADRs registered), only about half of them (51.43%) were reported to the Bolivian Pharmacovigilance system [61]. This data illustrate the urgency of implementing policies to promote training in pharmacovigilance to all healthcare professionals, as well as strictly recommend the follow-up on drug monitoring and ADR reporting.…”